Optimization of a Fast-track Concept for Knee Joint Replacement

Postoperative Pain Clinical Trial

— KneeOptOut2  

Official title:

Optimization of a Fast-track Concept for Knee Replacement: A Single-blind, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920930
• Other study ID #: KneeOptOut2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In an estimated 150,000 patients, a knee joint replacement is performed in Germany every year. The perioperative care of the patients aims at an optimal surgical technique, which leads to a high functionality in the joint, and above all at an adequate pain treatment. Patients experience pain especially intraoperatively and in the first days after the operation. The intensity of pain is a decisive factor that can hinder the patient's mobilization. In the KneeOptOut study (ethics application number EA4/009/17), which has already been successfully carried out and approved by this ethics committee, it was shown that the use of local infiltration anaesthesia (LIA) for pain therapy after primary knee endoprosthetics is comparable to catheter-supported regional anaesthesia (manuscript under review at the European Journal of Anaesthesiology). During surgery, the morphine requirement of patients in the LIA group was significantly higher than that of patients who underwent catheterization. Postoperatively, however, both subjective pain by VAS and opiate consumption were comparable.

In order to optimize the intraoperative opiate need/consumption, an early-intraoperative procedure for local infiltration anesthesia will now be compared with the previous late-intraoperative procedure. Both procedures correspond to SOP for the treatment of primary knee endoprostheses and are currently used depending on the surgeon's requirements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing elective, primary knee joint replacement in combined general anaesthesia

Exclusion Criteria:

• heart insufficiency NYHA >2

• liver insufficiency > CHILD B

• evidence of diabetic polyneuropathy

• severe adipositas BMI >40

• patients < 18 years

• pregnancy

• in case of police custody

• participation in a paralleled interventional RCT in a time frame of 30 days

• chronic opioid therapy >3 months before scheduled surgery

• allergy against medication required for surgery or anaesthesia

Related Conditions & MeSH terms

• Knee Arthropathy
• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• Late local infiltration analgesia
Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
• Early local infiltration analgesia
The local infiltration analgesia is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Kastelik J, Fuchs M, Kramer M, Trauzeddel RF, Ertmer M, von Roth P, Perka C, Kirschbaum SM, Tafelski S, Treskatsch S. Local infiltration anaesthesia versus sciatic nerve and adductor canal block for fast-track knee arthroplasty: A randomised controlled clinical trial. Eur J Anaesthesiol. 2019 Apr;36(4):255-263. doi: 10.1097/EJA.0000000000000929. — View Citation

Morin AM, Wulf H. [High volume local infiltration analgesia (LIA) for total hip and knee arthroplasty: a brief review of the current status]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2011 Feb;46(2):84-6. doi: 10.1055/s-0031-1272875. Epub 2011 Feb 10. German. — View Citation

Perret M, Fletcher P, Firth L, Yates P. Comparison of patient outcomes in periarticular and intraarticular local anaesthetic infiltration techniques in total knee arthroplasty. J Orthop Surg Res. 2015 Jul 31;10:119. doi: 10.1186/s13018-015-0249-x. — View Citation

Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017. — View Citation

Suthersan M, Pit S, Gordon L, Loman M, Pezzutti B, Freihaut R. Local infiltration analgesia versus standard analgesia in total knee arthroplasty. J Orthop Surg (Hong Kong). 2015 Aug;23(2):198-201. doi: 10.1177/230949901502300217. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	amount of opioids administered intraoperative measured as equivalent dose to morphin	intraoperative, up to 3 hours
Secondary	time to first mobilisation (standing)	time from end of surgery until patients is able to stand	up to 48 hours postoperatively
Secondary	patients satisfaction (11-point likert scale)	global satisfaction of patients	up to 7 days postoperatively
Secondary	time to first mobilisation (walking)	time from end of surgery until patients is able to walk	up to 7 days postoperatively
Secondary	time to achieve full joint mobility	time to achieve full joint mobility (0/0/90°)	up to 7 days postoperatively
Secondary	Janda grade of both legs at first day after surgery	best Janda grade in both legs the day after surgery	up to 24h postoperatively
Secondary	Pain intensity	intensity of pain in all patients meausered by numeric rating scale (NRS)	up to 7 days postoperatively
Secondary	rescue pain medication	number of patients requiring rescue pain medication	up to 7 days postoperatively
Secondary	time to discharge	time to discharge from hospital	up to 14 days postoperatively
Secondary	Opioid consumption (hospital)	amount of opioids administered until discharge measured as equivalent dose to morphin	up to 14 days postoperatively
Secondary	delirium	incidence of postoperative delirium measured by Nursing Delirium Screening Scale (NuDeSc)	up to 7 days postoperatively
Secondary	postoperative nausea and vomiting (PONV)	incidence of PONV	up to 7 days postoperatively
Secondary	surgeon satisfaction (6-point likert scale)	satisfaction of surgeon in points of clarity of the operative field, change of the operative field by LIA and overall satisfaction represented in one value	intraoperative, up to 3 hours